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关于授权部分药品委托生产审批事项的通知

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关于授权部分药品委托生产审批事项的通知

国家食品药品监督管理局


关于授权部分药品委托生产审批事项的通知

国食药监安[2003]48号



各省、自治区、直辖市药品监督管理局:

根据《药品管理法》第十三条的规定,为进一步贯彻落实国务院行政审批制度改革精神,合理划分审批事权,同时适应当前防治“非典”的需要,我局决定对部分药品委托生产审批事项授权省(区、市)药品监督管理局审批,现将有关事宜通知如下:

一、自发文之日起,除注射剂、生物制品和特殊药品外,其他药品委托生产的申请,委托双方在同一省(区、市)的,由企业所在地省、自治区、直辖市药品监督管理局负责受理和审批,并报国家食品药品监督管理局备案。注射剂、生物制品、特殊药品和跨辖区药品委托生产的审批,仍由国家食品药品监督管理局负责。有关药品委托生产的报批要求和工作时限等仍按国家药品监督管理局令第37号《药品生产监督管理办法》的有关规定执行。

二、在防治“非典”期间,国家食品药品监管局加快了对药品委托生产的审批。各省、自治区、直辖市药品监督管理局也要根据防治“非典”的需要,在保证审批质量的前提下,建立药品委托生产快速审批通道,以保障临床供应,维护药品市场稳定。

三、加强对委托生产审批的管理,严格按有关规定进行审批,对审批工作中发现的问题要及时报国家食品药品监督管理局;同时要加强对委托生产的日常监督检查,切实保证委托生产药品质量。对擅自委托和接受委托生产药品的企业,要按照《药品管理法》的有关规定予以查处。

四、国家食品药品监管局将加强药品委托生产审批工作的监督抽查,对省、自治区、直辖市药品监督管理局未按规定进行药品委托生产审批的,一经发现,将予以纠正,并视情作出是否收回其审批权限的决定。

特此通知


国家食品药品监督管理局
二○○三年五月十日

TRANSFER OF BUSINESSES (PROTECTION OF CREDITORS) ORDINANCE ——附加英文版

Hong Kong


TRANSFER OF BUSINESSES (PROTECTION OF CREDITORS) ORDINANCE
 (CHAPTER 49)
 Whole document:
  
  rotect creditors on the transfer of businesses, to provide 
for the
  ility of transferees of business, the manner in which such 
liability
  be avoided and for matters incidental thereto and connected
therewith,
  to repeal the Fraudulent Transfers of Businesses Ordinance.
  June 1980]
 1. Short title
  
  Ordinance may be cited as the Transfer of Businesses (Protection 
of
  itors) Ordinance.
 2. Interpretation
  
  In this Ordinance, unless the context otherwise requires--
  eal" includes a motion for a new trial or to set aside a 
verdict,
  ing or judgment;
  iness" means a business, or any part thereof, consisting of a
trade or
  pation (other than a profession) whether or not it is carried on 
with
  ew to profit; "charge" means--
  a debenture within the meaning of the Companies Ordinance (Cap.
32);
  a mortgage;
  a bill of sale;
  a lien; or
  any document,
  r or pursuant to which a business or any assets thereof are charged
as
  rity for the payment of money or the performance of an obligation,
and
  udes an equitable charge;
  rge-holder" means a person who, under or pursuant to a charge,
and for
  purpose of enforcing payment of any money or for the 
performance of
  obligation, may sell any business;
  e of transfer" means the date on which a transfer takes effect 
or is
  nded to take effect;
  ice of transfer" means a notice of transfer in accordance with
section
  registered charge" means a charge which is registered under--
  the Land Registration Ordinance (Cap. 128);
  the Companies Ordinance (Cap. 32);
  the Bills of Sale Ordinance (Cap. 20); or
  any other enactment;
  nsfer" means the transfer or sale of a business, but does not
include-
  the sale of the stock-in-trade of a business in the ordinary
course of
  trade;
  the creation of a charge;
  the transfer of land or any share or interest therein; or
  the transfer of a vessel (or the transfer of any interest or 
share
  ein), other than--
  a vessel to which Part IV of the Shipping and Port Control 
Ordinance
  . 313) applies; or
  a trawler to which Part XII of the Merchant Shipping Ordinance 
(Cap.
  applies; "transferee" means the person to whom a 
business is
  sferred by a transferor; "transferor" means--
  in the case of the sale of a business under or pursuant to a 
charge,
  person whose business has been or is intended to be sold;
  in every other case, the person by whom or on whose 
behalf the
  sfer has been or is intended to be made.
  For the purposes of this Ordinance "transferor" and 
"transferee"
  ectively include a sub-transferor and a sub-transferee.
 3. Transferee of business to be liable for liabilities of trans- 
feror
  
  Subject to this Ordinance, whenever any business is transferred, 
with
  ithout the goodwill thereof, the transferee shall,
notwithstanding any
  ement to the contrary, become liable for all the 
debts  and
  gations, including liability for tax charged or chargeable 
under the
  nd Revenue Ordinance (Cap. 112), arising out of the carrying on
of the
  ness by the transferor.
  Notwithstanding subsection (1), where a part of a 
business is
  sferred (other than the goodwill thereof) and in any
proceedings--
  the transferee would, but for this subsection, be adjudged 
liable
  r this Ordinance for any debts and obligations arising out 
of the
  ying on of the business by the transferor; and
  it is shown to the satisfaction of the court hearing the 
proceedings
  --
  the transferee purchased such part of the business in good faith 
and
  value; and
  at the date of transfer of such part of the business, the 
transferee
  no knowledge (whether actual, constructive or imputed)
  what he was acquiring formed part of a business,
  transferee shall not be liable under this Ordinance for the debts 
and
  gations arising out of the carrying on of the business 
by the
  sferor.
 4. Circumstances in which the transferee's liability ceases
  
  A transferee shall not become liable under section 3 if a 
notice of
  sfer has been given not more than 4 months, and not less than 1
month,
  re the date of transfer and has become complete at the 
date of
  sfer.
  Where a notice of transfer has been given but the notice 
has not
  me complete at the date of transfer, the liability of the 
transferee
  r section 3 shall cease with effect from the date on which the 
notice
  ransfer becomes complete.
  Where a notice of transfer has not been given before or at the
date of
  sfer, the liability of the transferee under section 3 shall cease
with
  ct from the date on which a notice of transfer, which is given 
after
  date of transfer, becomes complete.
  A notice of transfer shall, subject to subsections (5) and (6),
become
  lete upon the expiration of 1 month after the date of 
the last
  ication of the notice in accordance with section 5.
  Subject to subsection (6), in the case of a notice of 
transfer
  rred to--
  in subsection (1), if proceedings are instituted 
against  the
  sferor in respect of any liability of the transferor arising 
before
  notice has become complete and out of the carrying on 
of his
  ness; or
  in subsection (2) or (3), if proceedings are instituted 
against the
  sferee in respect of any liability of the transferee under 
section 3
  ing before such notice becomes complete,
  notice of transfer shall (for the purposes of such proceedings 
only)
  eemed incomplete pending the final determination of such 
proceedings,
  uding all possible appeals, and pending the expiration of all 
periods
  ng which such appeals may be brought.
  Where proceedings are instituted, a notice of transfer shall 
not be
  ed incomplete under subsection (5) unless within 1 month 
of the
  eedings being instituted--
  they are served on the transferor or transferee, as the case may 
be;
  
  written notice that they have been instituted is sent by 
registered
  to the last known address of such transferor or transferee.
 5. Contents of notice of transfer and manner of giving notice
  
  Except in the case of a transfer by way of sale under or pursuant
to a
  ge, a notice of transfer shall contain the following
particulars--
  the full name and address of the transferor;
  the nature of the business and the name or style under which, and 
the
  address at which, it has been carried on during the period 
of 6
  hs immediately preceding the date of transfer;
  the date of transfer;
  the full name and the residential and business addresses 
of the
  sferee;
  if the transferee--
  intends to carry on or is carrying on the business, the full 
address
  e, and the name and style under which, he is carrying it on or
intends
  arry it on; or
  is not carrying on the business and does not intend to carry it
on, a
  ement to that effect; and
  a statement that at the expiration of 1 month after the date of 
the
  publication of the notice pursuant to subsection (3), the 
liability
  he transferee for all the debts and obligations arising out 
of the
  ying on of the business by the transferor shall cease by 
virtue of
  Ordinance unless proceedings are instituted prior to such
expiration.
  In the case of a transfer by way of sale under or pursuant 
to a
  ge, a notice of transfer shall contain the following
particulars--
  the nature of the business, and the name or style under which,
and the
  address at which, it has been carried on during the period 
of 3
  hs immediately preceding the date of transfer;
  the full name and address of the person whose business has been,
or is
  nded to be, transferred by way of sale under or pursuant 
to the
  ge;
  details of the charge under or pursuant to which the transfer by 
way
  ale has been or is to be made, sufficient to enable any 
document
  ting or evidencing the charge to be readily identified and, 
without
  ting the generality of the foregoing, such details shall
include--
  the date when the charge was made, given, executed or 
came into
  tence;
  the consideration for which the charge was executed, made or 
given
  if there was no such consideration, the circumstances in which
it came
  existence;
  ) in the case of a registered charge, the date of the registration 
of
  charge, the title of any enactment under which it was registered 
and
  number or other means of identifying the charge assigned to it 
upon
  stration;
  the date of transfer; and
  the amount of money, payment of which has been secured by the 
charge
  which was owing--
  at the date of the publication of the notice of transfer; or
  if the transfer has already taken effect, at the date of the
transfer
  aking effect.
  Every notice of transfer shall be signed--
  by both the transferor and the transferee, in the case of a 
transfer
  hich subsection (1) applies; or
  by the charge-holder and the transferee, in the case of a transfer 
to
  h subsection (2) applies,
  shall be given by publication in--
  the Gazette;
  any 2 of such Chinese language newspapers circulating in Hong Kong
as
  be approved for the purpose by the Chief Secretary; and (Amended
L. N.
  f 1985; L. N. 242 of 1989)
  ) 1 English language newspaper circulating in Hong Kong which has
been
  pproved.
 6. Right of transferee to indemnity
  
  The transferee shall be entitled to be indemnified--
  by the transferor, except in the case of a transfer by way of 
sale
  r or pursuant to a charge; or
  by the charge-holder, if the transfer is by way of sale 
under or
  uant to a charge,
  all amounts for which the transferee is made liable 
under this
  nance and for which he would not otherwise be liable.
  The amount of such an indemnity may be recovered by civil 
proceedings
  debt or liquidated demand.
 7. Liability of parties not affected
  
  ing in this Ordinance shall relieve or be deemed to 
relieve a
  sferor or transferee, or any person who sells a business 
under or
  uant to a charge, from any liability to which he would 
otherwise be
  ect.
 8. Limitation of liability of transferee
  
  A transferee who in good faith and without preference has 
paid in
  harge or partial discharge of any liability for which he became
liable
  r this Ordinance, and for which he would not otherwise 
have been
  le, an amount which is equal to the value of the business acquired 
by
  at the date on which the transfer took effect, shall not be 
liable
  her under this Ordinance.
  The value of a business acquired by a transferee at the date on 
which
  transfer takes effect shall, until the contrary is proved, be
presumed
  e an amount equal to the amount paid or agreed to be paid (whether 
in
  s of money or by means of any other consideration) for the
acquisition
  he business.
 9. Limitation of time for institution of proceedings
  
  ect to section 6, no action shall be instituted to recover any 
debt
  or to enforce any obligation against any person liable therefor
under
  Ordinance, and for which he would not otherwise have been 
liable,
  than 1 year after the date on which the transfer in respect of 
which
  liability arose took effect.
 10. Saving
  
  Ordinance shall not apply to any transferee where the transfer
  ffected--
  by the Official Receiver or a trustee in bankruptcy;
  by the liquidator of a company in liquidation other than 
voluntary
  idation;
  by the Financial Secretary Incorporated; (Amended L. N. 369 of
1989)
  by the Director of Education Incorporated;
  by the Director of Social Welfare Incorporated;
  by a person selling under or pursuant to a charge which has 
been
  stered for not less than 1 year at the date when the transfer 
takes
  ct;
  pursuant to any order or direction of any court;
  by an executor or administrator; or
  by operation of law.
 11. Repeal and saving
  
  The Fraudulent Transfers of Businesses Ordinance (Cap. 49, 1964 
Ed.)
  epealed.
  Notwithstanding subsection (1), the Fraudulent Transfers of
Businesses
  nance (Cap. 49, 1964 Ed. ) shall continue to apply with respect 
to a
  sfer--
  which took effect; and
  in respect of which notice was given under section 3 
of that
  nance, before the coming into operation of this Ordinance, as if 
this
  nance had not been passed.


国家外汇管理局关于印发《银行执行外汇管理规定情况考核办法(试行)》的通知

国家外汇管理局


国家外汇管理局关于印发《银行执行外汇管理规定情况考核办法(试行)》的通知

文号:汇发[2008]40号 


国家外汇管理局各省、自治区、直辖市分局、外汇管理部,深圳、大连青岛厦门、宁波市分局;各中资外汇指定银行:
为激励银行贯彻和实施外汇管理规定,促进银行依法合规经营,根据《中华人民共和国外汇管理条例(中华人民共和国国务院令[2008]第532号)《金融违法行为处罚办法(中华人民共和国国务院令[1999]第260号)及相关规定,国家外汇管理局制定了《银行执行外汇管理规定情况考核办法(试行)(见附件,以下简称《办法)。现就有关问题通知如下:
一、国家外汇管理局各分局、外汇管理部接到本通知后,应立即转发辖内支局、城市商业银行农村商业银行外商独资银行、中外合资银行、外国银行分行以及农村合作金融机构,尽快完成对所辖支局、银行的业务操作培训,严格遵照《办法》规定,公平、公正地开展对辖内银行的考核工作。
二、各中资外汇指定银行应尽快转发所辖分支机构,认真落实《办法》的相关要求,依法合规办理各项业务。
三、2008年度外汇局对银行考核的周期为9月1日至12月31日。
执行中如遇问题,请及时向国家外汇管理局相关部门反馈。联系电话:010-68402129(综合司),68402464(国际收支司),68402282(经常项目管理司),68402366(资本项目管理司),68402050(管理检查司)
特此通知。


附件: 《银行执行外汇管理规定情况考核办法(试行)》



第一条 为激励银行认真贯彻和实施外汇管理规定,促进银行依法合规经营,根据《中华人民共和国外汇管理条例》、《金融违法行为处罚办法》等相关规定,制定本办法。
第二条 国家外汇管理局及其分支局(以下简称外汇局)对银行执行外汇管理规定的情况按年度进行考核。考核周期为每年1月1日至12月31日。
第三条 考核内容、方法和标准由国家外汇管理局统一制定。外汇局设立考核工作小组,负责实施具体考核工作。
第四条 考核内容及分值:
(一)业务合规,占60分。考核银行按外汇管理规定办理相关业务情况。
(二)数据质量,占30分。考核银行按外汇管理规定及时、准确、完整报送相关数据、信息和报表情况。
(三)内控制度,占6分。考核银行执行外汇管理规定的相关内控制度建立情况,监督执行情况。
(四)其他,占4分。考核银行对外汇管理规定的培训、宣传情况,对外汇管理工作要求的配合、落实情况,检查情况。
对于管理权在银行总行(外国银行分行头寸集中管理行、主报告行、短期外债管理行等视为总行)的业务,设置总行单独考核指标。总行单独考核指标不作为对银行分支机构的考核内容。
对于仅由部分银行开办的特殊业务,作为附加项目由外汇局相关部门进行专项考核。
第五条 考核评分采取扣分方式。外汇局按照本办法第四条所列考核内容及相应考核标准(详见附1),以日常监管中发现银行存在的问题作为依据,并结合现场核查,进行各项目分值扣减。
对于银行没有开办相应业务的考核指标,不予考核,为保持与开办相应业务银行的可比性,在计算此类银行总分值时将参照该银行其它同类指标的得分情况予以调整。
第六条 外汇局对银行考核,按法人和属地相结合方式进行。
(一)政策性银行和全国性商业银行(国有商业银行和股份制商业银行)总行由国家外汇管理局负责。
(二)上述银行的分支机构、城市商业银行、农村商业银行、外商独资银行、中外合资银行、外国银行分行以及农村合作金融机构,由所在地外汇局负责。
(三)外汇管理权限下放的,由所在地外汇局负责考核。
第七条 银行考核结果汇总方法为:
(一)外汇局各业务部门将银行各分支机构实际考核得分根据其同期国际收支业务量(国际收支申报笔数)加权平均后,计算该银行单项指标最后考核得分,即:
银行单项指标考核结果=(下级行1得分×该行国际收支申报笔数+下级行2得分×该行国际收支申报笔数+……)/(下级行1国际收支申报笔数+下级行2国际收支申报笔数+……)
对于银行总行和分支机构共有的考核指标,将总行视为一家分支机构,与其他分支机构的得分一并汇总。
(二)考核工作小组将银行单项指标得分之和乘以90%,再与总行单独考核指标得分加总,作为银行全行最终考核结果,即:
银行全行最终考核结果= ∑银行全行各单项指标得分(总行单独考核指标除外)×90%+总行单独考核指标得分
附加项目得分在计算银行最终考核成绩时予以单列。
第八条 银行考核结果的报送程序如下:
(一)外汇局业务部门在评分完成后应将政策性银行、全国性商业银行(国有商业银行和股份制商业银行)分支机构的考核结果分别汇总,以书面形式报送至上一级外汇局对应业务部门(报表格式详见附2)。计划单列市分局应将辖内银行的考核结果直接上报国家外汇管理局,同时抄送所在地外汇局省级分局。
对于跨地区经营的外商独资银行、中外合资银行和城市商业银行分支机构的考核结果,由所在地外汇局以书面形式告知该银行总行所在地外汇局。
国家外汇管理局各分局、外汇管理部(以下简称各分局)业务部门应于每年2月15日之前将辖内银行的上一年度考核结果报送国家外汇管理局对应业务部门。
(二)外汇局业务部门将银行单项业务考核结果汇总后报本级外汇局考核工作小组。
第九条 外汇局根据银行最终考核结果,将被考核银行评定为A、B、C三类,并就银行执行外汇管理规定情况形成整体评估报告。
各分局考核工作小组应于每年3月15日之前向国家外汇管理局考核工作小组提交对辖内银行的考核评估报告。
第十条 外汇局应于每年3月底前将银行上一年度的考核结果和评定等级采取适当方式通知被考核银行,并视情况将银行执行外汇管理规定的整体评估情况予以上报、公布。
第十一条 外汇局对银行进行考核,应留存相应业务记录,并保留24个月。
第十二条 外汇局应将考核中发现的问题及时与银行沟通,督促银行整改。
第十三条 国家外汇管理局各业务部门应对下级外汇局的考核工作予以监督指导。
第十四条 本年度新开设的银行自下一年度参加考核。
第十五条 本办法由国家外汇管理局负责解释。
第十六条 本办法自2008年9月1日起实施。

附:
1、银行执行外汇管理规定情况考核内容及评分标准(试行)
2、银行执行外汇管理规定情况考核评分成绩表